MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient contact discovered a fluid leak during an unknown phase of treatment.The patient was connected during the incident.Fluid was not discovered in the pump module area or on the external of the cassette.Fluid leaked from an unknown location, but per the patient contact, the unused lines were unclamped.Upon follow up, the patient contact confirmed the reported event.The patient contact stated waking up in the middle of the night to find the cycler cassette door being open and solution was all over the carpet.There was no fluid inside the cycler cassette door.The patient contact then checked the external baxter last bag and found that 1/4 cup of fluid had leaked from inner bag to outer wrap with additional fluid leaking onto the carpet.The patient contact could not confirm if the leak was from the bag itself or the adapter connection.The patient contact confirmed there was no leaking from the fresenius solution bags.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set and solution bags were discarded and not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient contact discovered a fluid leak during an unknown phase of treatment.The patient was connected during the incident.Fluid was not discovered in the pump module area or on the external of the cassette.Fluid leaked from an unknown location, but per the patient contact, the unused lines were unclamped.Upon follow up, the patient contact confirmed the reported event.The patient contact stated waking up in the middle of the night to find the cycler cassette door being open and solution was all over the carpet.There was no fluid inside the cycler cassette door.The patient contact then checked the externeal baxter last bag and found that 1/4 cup of fluid had leaked from inner bag to outer wrap with additional fluid leaking onto the carpet.The patient contact could not confirm if the leak was from the bag itself or the adapter connection.The patient contact confirmed there was no leaking from the fresenius solution bags.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set and solution bags were discarded and not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius safe lock apd luer lock connectors shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 20796573
• Report Number: 0008030665-2024-01146
• Device Sequence Number: 6754806
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95018
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Male